European Regulatory Affairs Manager | Kinetica

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European Regulatory Affairs Manager

49883
  • England
  • Permanent

European Regulatory Affairs Manager - North London 

About the Company:

We’re looking for an experienced pharmaceutical RA professional to join a world-renowned organisation at their site North of London. As RA Manager, your primary responsibility is the management of MAA and variations of MA for existing products in the UK and EU. 

Responsibilities:

  • Preparing and filing regulatory submissions.
  • Developing and leading the implementation of regulatory strategies.
  • Maintaining policies to ensure compliance.
  • Supporting project teams.
  • Providing information and document review for QPPV.
  • Implementing changes required by PV guidelines.
  • Tracking PV activities.

Requirements:

  • Successful candidates will have a range of pharmaceutical RA experience including submission experience in the UK and EU. T
  • Must have a good knowledge of UK GMP and EU GMP, and experience communicating with European authorities.
  • Ideally candidates will also have a degree in life sciences.
Claire Collinson Client Director Regulatory, Quality & R&D Recruitment

Apply for this role

  • info@kinetica.co.uk
  • +44 (0)113 261 71 81
  • Kinetica (UK) Ltd, Floor 13, Whitehall Waterfront, 2 Riverside Way, Leeds, LS1 4EH, UK